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Completed

NCT Number: NCT04217031

Decision Variability Between Different Heart Teams for Complex Coronary Artery Diseases

The purposes of this study are 1) to explore the variability of decisions between different heart teams in complex coronary artery disease; 2) to evaluate the reasons of the discrepancy in decision making.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai hospital

Beijing, Beijing Municipality, 100032, China

About this study

Heart team has been recommended by guideline for optimizing the decision making for patients with complex coronary artery diseases (CAD). However, prior studies have demonstrated that heart team decision might have poor reproducibility, and the variability of heart team decision remains unknown.

Thus, the investigators designed a single-center, retrospective, cross-sectional study to explore the decision variability of heart team in CAD patients. The investigators will retrospectively recruit patients with angiographically confirmed 3-vessel or left main disease from a coronary angiography database at Fuwai hospital. Patients' baseline information will be collected. And different heart teams will be established and made decisions for the enrolled patients. First, the investigators will assess the decision variability between different heart teams. Secondary, the investigators will evaluate the reason of discrepancy by qualitative and quantitative analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with angiographically confirmed 3-vessel disease or left main disease

Exclusion criteria

  • Prior percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
  • Myocardial infarction with acute phase judged by Electrocardiograph or biomarkers
  • Combined with severe valvular disease, great vessel disease or huge ventricular aneurysm which need surgery
  • Combined with atrial fibrillation or severe arrhythmia

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Kappa value of decisions

    Time frame: at the end of enrollment (6 months)

    Kappa value of decisions between different heart teams

Secondary outcomes

  1. Concordance rate of decisions

    Time frame: at the end of enrollment (6 months)

    Concordance rate of decisions between different heart teams

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

Decision Variability Between Different Heart Teams for Complex Coronary Artery

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 3, 2020
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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